Manufacturing Engineer
Location – Portland, Oregon, USA
Intake Notes:
- Engineering professional individual contributor with comprehensive knowledge in the area of Manufacturing Process and Process Development.
- Ability to execute highly complex or specialized projects.
- Performs analyses to develop design specifications and performance requirements.
- Provides technical information concerning manufacturing or processing techniques, materials, properties and process engineering planning
- Ability to establish processes based on product specifications
- Evaluate process and design alternatives based on Design for Manufacturability principles.
- Develops procedures for the economical mass production in cooperation with pilot and production departments
- Services, troubleshoots and solves production process problems with processes or equipment already in operation Experience
- Experience in designing and developing manufacturing processes for medical device products, or similar, taking into consideration problems inherent in the transfer of technology from research to manufacturing
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Ability to leverage and/or engage others to accomplish projects.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
- Minimum 5 years experience in NPI, NDP, New Product Development focused on process development, documentation and validation.
Experience:
- Minimum 5 years, preferably senior level.
Responsibilities:
– Transitioning products from R&D to production.
– Conducting pilot builds and device verification.
– Performing testing builds.
– Implementing FDA/ISO medical device process validation.
Skills:
– Equipment IQ/OQ/PQ.
– Knowledge of ISO 13485 and FDA 21 CFR Part 820.
– Experience in thermoplastics injection molding.
Education:
– Bachelor’s degree in manufacturing, industrial engineering, or mechanical engineering.
Preferred Skills:
– Cable assembly expertise (extrusion, cabling, braiding, shielding, connector termination).
– Hands-on collaboration in a cross-functional team environment.
– Designing and developing manufacturing processes.
– Document writing/editing, including process documentation.
– Reviewing process tooling and specifications.
– Understanding geometric dimensioning and tolerancing.
– Background in NPI and new product development.
– Medical device manufacturing experience.
– Materials background, especially in thermoplastics.